FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2082150
·
Received April 28, 2011
Report
- Report Number
- 3002158293-2011-00470
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 13, 2011
- Report Date
- April 26, 2011
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY CHARGER CONNECTOR WAS CORRODED. THE CAUSE FOR THE CORRODED CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATION BATTERY CHARGER CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERIES WERE NOT CHARGING PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |